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Trial registered on ANZCTR


Registration number
ACTRN12616000563460
Ethics application status
Approved
Date submitted
17/02/2016
Date registered
2/05/2016
Date last updated
26/04/2022
Date data sharing statement initially provided
3/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D and Exercise to Improve Physical Function in Older Adults
Scientific title
Vitamin D Supplementation and Exercise for Improving Physical Function in Overweight and Obese Older Adults With Low Vitamin D Levels
Secondary ID [1] 288521 0
Nil
Universal Trial Number (UTN)
Trial acronym
DE-x Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 297599 0
Mobility Limitation 297600 0
Insulin Resistance 297601 0
Cardiometabolic Health 297602 0
Condition category
Condition code
Musculoskeletal 297794 297794 0 0
Other muscular and skeletal disorders
Diet and Nutrition 297795 297795 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4000IU/day vitamin D plus progressive multi-modal exercise training.
The 24-week intervention period is divided into two 12-week phases: "pre-training", involving commencement of 4,000 International Units per day of vitamin D3 or placebo, and "training", involving commencement of the exercise protocol while maintaining the vitamin D supplementation protocol. The exercise protocol consists of three sessions per week. It will be administered by a trained exercise scientist in a group session once per week and then the participants complete a further two sessions at their home unsupervised. The training consists of progressive lower limb resistance and aerobic training targeting improvements in mobility and cardiovascular fitness. At the end of pre-training compliance by capsule count will be conducted as a proxy for adherence to the protocol. Each session consists of a warm-up (slow walking and stretching, 10 minutes), followed by approximately 1 hour of aerobic training (moderate-intensity walking or jogging, approximately 30 minutes) and resistance training (leg-strengthening exercises including knee extension and flexion, squats, side leg raises and calf raises, approximately 30 minutes), and a cool-down (slow walking and stretches, 10 minutes). Participants will be instructed to complete aerobic and resistance training exercises at moderate intensity, based on self-perceived exertion reported on the Borg scale. All participants will be provided with adjustable leg weights for the purpose of completing resistance training during home-based exercise. Participants will be instructed on the use of these weights during supervised sessions, where assessments will be performed to determine whether participants are ready to increase weight amounts for the subsequent week. Participants will also be provided with an instruction booklet, along with their physical activity diary, which details exercise movements and use of leg weights. Supervisors will monitor the conduct of the participants to ensure safety.
Intervention code [1] 293885 0
Lifestyle
Intervention code [2] 294264 0
Treatment: Other
Comparator / control treatment
Placebo plus progressive multi-modal exercise training. The placebo will be a colour, size and shape matched sugar capsule to the investigational vitamin D.
Control group
Placebo

Outcomes
Primary outcome [1] 297320 0
A clinically meaningful change in usual gait speed (mean: 0.10 m/s; SD 0.12 m/s) over a 2.44-metre course
Timepoint [1] 297320 0
Baseline, 12 and 24 weeks
Secondary outcome [1] 320726 0
Inflammation by measuring serum high-sensitivity C-reactive protein conducted by trained technicians from Monash Pathology at Monash Medical Centre,
Timepoint [1] 320726 0
Baseline, 12 and 24 weeks
Secondary outcome [2] 322070 0
Body composition was assessed using whole-body dual-energy X-ray absorptiometry (DXA) scans (Hologic Discovery W, Hologic, USA) and by measuring waist and hip circumference.
Timepoint [2] 322070 0
Baseline, 12 and 24 weeks
Secondary outcome [3] 322071 0
Bone health: Peripheral quantitative computed tomography (pQCT) scans will be performed in the participant’s non-dominant lower-leg. Both regular (Stratec XCT 3000, Stratec, Germany) and high-resolution (HR-pQCT; Scanco Xtreme CT II) scans of the tibia will be performed.
Timepoint [3] 322071 0
Baseline, 12 and 24 weeks
Secondary outcome [4] 322072 0
Vascular health: Blood pressure and Arterial Stiffness will be measured using a digital blood pressure and pulse wave analysis monitor (Mobil-O-Graph, NG apparatus, I.E.M., Stolberg, Germany).
Timepoint [4] 322072 0
Baseline, 12 and 24 weeks
Secondary outcome [5] 409087 0
Physical function: (1) hand grip strength using a Jamar hydraulic hand grip dynamometer (Lafayette Instrument Company, USA) (2) Knee Extension Strength in both legs using a Baseline cable tensiometer (Fabrication Enterprises, USA) (3) 400 Metre Walk time measured by a stopwatch and conducted on the grounds of the hospital (4) Short Physical Performance Battery consisting of Repeated Chair Stands from a normal chair, Standing Balance, Gait Speed Test on a short 2.44m walking flat course (5) Stair Climb Power Test conducted in the stairwell of a flight of 10-steps.
Timepoint [5] 409087 0
Baseline, 12 and 24 weeks
Secondary outcome [6] 409088 0
Metabolic health: serum triglyceride, glucose, insulin, high- and low-density lipoprotein cholesterol and 25-hydroxyvitamin D concentrations will be analysed by trained technicians from Monash Pathology at Monash Medical Centre
Timepoint [6] 409088 0
Baseline, 12 and 24 weeks

Eligibility
Key inclusion criteria
Community-dwelling; age 50-80 years; BMI 25-40 (overweight or obese); low vitamin D status (serum 25-hydroxyvitamin D [25OHD] less than or equal 49.9nmol/L); willing, and has GP approval, to complete a 12-week exercise intervention, willing to be randomised to either vitamin D or placebo.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Self-reported inability to unable to walk 400 metres non-stop unassisted (ie. without use of walking aids); non-English speaking; vitamin D supplementation greater than or equal to 1000 International Units/day; 4 weeks self-reported participation in a supervised exercise program targeted at weight loss or strength gains in the past six months; planning to be away from home for more than 2 weeks during the training phase; women who are pregnant or are trying to become pregnant; and self-reported diagnosis of: Progressive neurological disorders including Parkinson’s Disease and multiple sclerosis; schizophrenia or bipolar disorder; severe knee or hip osteoarthritis (awaiting a joint replacement) that would interfere with ability to complete functional tests; lung disease requiring regular use of supplemental oxygen; renal disease requiring dialysis, any other disorder of such severity that life expectancy is less than 12 months; and stroke, hip or knee replacement, spinal surgery, myocardial infarction or major heart surgery in the past 6 months. Also, use of medications contraindicated for vitamin D supplementation including: thiazide diuretics, cholestyramine, colestipol, corticosteroids, mineral oil, orlistat, phenytoin, barbiturates, digitalis glycosides, and antacids (magnesium).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation was concealed using unmarked, sealed containers (containing either vitamin D or placebo capsules) that only had unique study participant identification numbers attached to containers by suppliers. All capsules were identical and tasteless.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was performed by an independent statistician and unavailable to study staff involved in outcome assessments or delivery of the intervention.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
3/01/2020
Date of last data collection
Anticipated
Actual
3/07/2020
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292870 0
University
Name [1] 292870 0
Monash University (Prof. Peter Ebeling)
Country [1] 292870 0
Australia
Primary sponsor type
Individual
Name
Prof. Peter Ebeling
Address
School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E,
Monash Medical Centre,
246 Clayton Road,
Clayton,
Victoria, Australia 3168.
Country
Australia
Secondary sponsor category [1] 291614 0
None
Name [1] 291614 0
None
Address [1] 291614 0
None
Country [1] 291614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294372 0
Monash Health HREC
Ethics committee address [1] 294372 0
Research Support Services, Monash Health, Level 2, I Block, Monash Medical Centre, Clayton, 3168, VIC
Ethics committee country [1] 294372 0
Australia
Date submitted for ethics approval [1] 294372 0
14/12/2015
Approval date [1] 294372 0
01/04/2016
Ethics approval number [1] 294372 0
HREC: #15521A, SSA: #SSA/16/MonH/116

Summary
Brief summary
This pilot, double-blind, placebo controlled randomised controlled trial entitled “Vitamin D supplementation and exercise for improving physical function overweight and obese older adults with low vitamin D” is supported by research funding from Monash University’s School of Clinical Sciences “NearMiss” Grant Scheme.
Mobility limitation and insulin resistance are common in overweight and obese older adults, and infiltration of adipose tissue into skeletal muscles, known as inter and
intramuscular adipose tissue (IMAT) is implicated in the pathogenesis of these conditions, potentially due to proinflammatory effects. Exercise reduces IMAT and so may be
important for improving health in older adults, but individuals with high initial IMAT levels may experience attenuated functional and metabolic gains in response to exercise. Adjunctive therapies may therefore be beneficial in overweight and obese older adults to potentiate effects of exercise by reducing IMAT and improving physical function
and cardiometabolic health. We hypothesise that correction of low vitamin D status, which is common in overweight and obese older adults, may be effective in reducing IMAT levels, improving physical function,cardiometabolic health and bone health. We will conduct a pilot randomised controlled trial (RCT) of vitamin D supplementation or placebo plus exercise in 50 overweight and obese older adults for 24 weeks.. Primary outcome measures will be changes in physical function IMAT, insulin sensitivity, bone health and arterial stiffness. The findings from this pilot RCT will increase our understanding of the role of vitamin D in muscle function and cardiometabolic health, and contribute to the development of nationally competitive grant applications for further research into exercise and vitamin D supplementation in older adults.
Trial website
https://www.monash.edu/medicine/scs/medicine/research/bone-muscle/d-ex-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63474 0
Prof Peter Ebeling
Address 63474 0
School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E,
Monash Medical Centre,
246 Clayton Road,
Clayton,
Victoria, Australia 3168.
Country 63474 0
Australia
Phone 63474 0
+613 8572 2570
Fax 63474 0
Email 63474 0
[email protected]
Contact person for public queries
Name 63475 0
David Scott
Address 63475 0
School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E,
Monash Medical Centre,
246 Clayton Road,
Clayton,
Victoria, Australia 3168.
Country 63475 0
Australia
Phone 63475 0
+61 3 8572 2397
Fax 63475 0
Email 63475 0
[email protected]
Contact person for scientific queries
Name 63476 0
David Scott
Address 63476 0
School of Clinical Sciences,
Faculty of Medicine, Nursing and Health Sciences,
Monash University,
Level 5 / Block E,
Monash Medical Centre,
246 Clayton Road,
Clayton, Victoria 3168
Country 63476 0
Australia
Phone 63476 0
+613 8572 2919
Fax 63476 0
Email 63476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Line-by-line individual patient data, after de-identification, can be made available by the corresponding author or lead investigator upon reasonable request.
When will data be available (start and end dates)?
Beginning 6 months after main results publication; no end date determined.
Available to whom?
Researchers who present a methodologically sound proposal or on a case-by-case basis at the discretion of the lead investigator.
Available for what types of analyses?
Only to achieve the aims in approved proposals.
How or where can data be obtained?
Contact corresponding author on primary article and/or the lead investigator of the study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVitamin D supplementation and exercise for improving physical function, body composition and metabolic health in overweight or obese older adults with vitamin D deficiency: a pilot randomized, double-blind, placebo-controlled trial.2023https://dx.doi.org/10.1007/s00394-022-03038-z
N.B. These documents automatically identified may not have been verified by the study sponsor.